Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06773832

Artificial Intelligence to Predict Pathology and Endoscopic Classification of Colorectal Polyps During Colonoscopy

Led by Peking Union Medical College Hospital · Updated on 2025-01-14

400

Participants Needed

1

Research Sites

99 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating an artificial intelligence (AI) model to predict the pathology and endoscopic classification of colorectal polyps during colonoscopy. Colonoscopy with optical diagnosis helps guide treatment and reduce unnecessary procedures, easing the burden on patients and healthcare systems. While current methods require extensive training and have limitations in accurately diagnosing all polyp types, AI-based computer-aided diagnosis (CADx) is rapidly developing and has shown promising accuracy for small lesions under 5mm. However, its effectiveness for larger polyps and serrated lesions, which are precancerous and more difficult to assess, remains unclear. The study involves developing an AI model using a large dataset of approximately 1600 cases, including serrated lesions, hyperplastic polyps, conventional adenomas, and early-stage colorectal cancer, collected retrospectively from pathology records. The model is built using popular AI classification algorithms and trained on static images linked to pathological diagnoses and endoscopic classifications. After optimization, the AI model's performance will be compared with that of endoscopists in a prospective cohort to assess its diagnostic accuracy. Participants are adults aged 18 years or older undergoing routine colonoscopy screening at multiple hospital centers who understand the study and provide consent. Researchers will collect data during colonoscopy and compare AI predictions to pathological outcomes. The main outcome measured is the accuracy of the AI optical diagnosis for colorectal polyps over two years. The study excludes individuals with certain serious health conditions, pregnancy, or prior colorectal surgery to ensure participant safety and data reliability.

CONDITIONS

Official Title

AI in Predicting Polyp Pathology and Endoscopic Classification

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients or inpatients undergoing routine colonoscopy screening at the endoscopy centers of multicenter hospitals
  • Aged 18 years or older
  • Have understanding of the study content and have signed the informed consent form
Not Eligible

You will not qualify if you...

  • Gastroparesis or gastric outlet obstruction
  • Known or suspected intestinal obstruction or perforation
  • Severe chronic renal failure (creatinine clearance less than 30 mL/minute)
  • Severe congestive heart failure (New York Heart Association Class III or IV)
  • Currently pregnant or breastfeeding
  • Toxic colitis or megacolon
  • Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg)
  • Moderate or massive active gastrointestinal bleeding (>100 mL/day)
  • Significant psychiatric or psychological illness
  • Allergy to medications used for bowel preparation
  • Patients who have undergone colorectal surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, China, 100730

Actively Recruiting

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Research Team

W

Wenmo Hu, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Optical diagnosis of colorectal polyp images using a newly developed computer-aided diagnosis system (CADx) compared with intuitive optical diagnosis.

Quirine E W van der Zander, Ramon M Schreuder, Roger Fonollà...

https://pubmed.ncbi.nlm.nih.gov/33368056

Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study.

Colin J Rees, Praveen T Rajasekhar, Ana Wilson...

https://pubmed.ncbi.nlm.nih.gov/27196576

Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps.

Joep E G IJspeert, Barbara A J Bastiaansen, Monique E van Leerdam...

https://pubmed.ncbi.nlm.nih.gov/25753029

Aim to unify the narrow band imaging (NBI) magnifying classification for colorectal tumors: current status in Japan from a summary of the consensus symposium in the 79th Annual Meeting of the Japan Gastroenterological Endoscopy Society.

Shinji Tanaka, Yasushi Sano

https://pubmed.ncbi.nlm.nih.gov/21535219

High-resolution chromoendoscopy for the diagnosis of diminutive colon polyps: implications for colon cancer screening.

A M Axelrad, D E Fleischer, A J Geller...

https://pubmed.ncbi.nlm.nih.gov/8613016

Cost savings in colonoscopy with artificial intelligence-aided polyp diagnosis: an add-on analysis of a clinical trial (with video).

Yuichi Mori, Shin-Ei Kudo, James E East...

https://pubmed.ncbi.nlm.nih.gov/32240683

ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps.

ASGE Technology Committee, Barham K Abu Dayyeh, Nirav Thosani...

https://pubmed.ncbi.nlm.nih.gov/25597420